FDA

FDA Approves Semiglutide for Type 2 Diabetes

FDA Approves Semiglutide for Type 2 Diabetes

Semaglutide helps patients with diabetes reduce blood glucose levels and lower body weight.

Drug Approved for Complicated Urinary Tract Infections

Drug Approved for Complicated Urinary Tract Infections

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Vabomere, which combines meropenem and vaborbactam, demonstrated superior efficacy to piperacillin/tazobactam.

FDA May Lower Nicotine Levels in Cigarettes to Non-Addictive Levels

FDA May Lower Nicotine Levels in Cigarettes to Non-Addictive Levels

The FDA is delaying implementation of last year's rules on cigars and electronic cigarettes currently on the market until 2021 and 2022, respectively.

FDA Will Increase Generic Drugs

FDA Will Increase Generic Drugs

The agency will now give priority reviews to new generic drugs until there are 3 on the market.

FDA: Canagliflozin May Increase Risk of Foot, Leg Amputations

FDA: Canagliflozin May Increase Risk of Foot, Leg Amputations

Amputations of the toe and middle of the foot were the most common, but leg amputations below and above the knee also occurred.

Anemia Indication Sought for Phosphate Binder

Anemia Indication Sought for Phosphate Binder

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Company asks FDA to approve ferric citrate for iron deficiency anemia in patients with non-dialysis dependent chronic kidney disease.

First Drug Approved to Treat Nocturnal Polyuria

First Drug Approved to Treat Nocturnal Polyuria

Noctiva is taken 30 minutes before bed and is designed to increase absorption of water through the kidneys.

Nivolumab Approved for Refractory Urothelial Carcinoma

Nivolumab Approved for Refractory Urothelial Carcinoma

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The drug is indicated for treating patients with locally advanced or metastatic disease that progresses despite platinum-containing chemotherapy.

Bladder Cancer-Pioglitazone Link Reasserted by FDA

Bladder Cancer-Pioglitazone Link Reasserted by FDA

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After analyzing new data, the FDA again warns that the diabetes drug may be associated with an increased risk for bladder cancer.

FDA Approves Removal of Boxed Warning for Hyperkalemia Drug

FDA Approves Removal of Boxed Warning for Hyperkalemia Drug

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Updated label for patiromer now recommends the drug be taken at least 3 hours before or after other oral medications.

FDA Adds Abuse Warning to All Testosterone Products

FDA Adds Abuse Warning to All Testosterone Products

The new FDA warning alerts prescribers to the abuse potential of testosterone.

FDA Adds New Testosterone Warnings

FDA Adds New Testosterone Warnings

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Labeling changes will alert prescribers to the abuse potential of testosterone and the serious adverse effects.

FDA Approves Enzalutamide Labeling Update

FDA Approves Enzalutamide Labeling Update

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Labeling information will include data showing the drug reduces the risk of radiographic progression versus bicalutamide.

FDA Approving More Abuse-Deterrent Opioids

FDA Approving More Abuse-Deterrent Opioids

While ADFs of opioids may help mitigate the risk of opioid abuse, they have limitations as well.

FDA Approves Adlyxin to Treat Type 2 Diabetes

FDA Approves Adlyxin to Treat Type 2 Diabetes

Once-daily injection to improve glycemic control, along with diet and exercise.

FDA Adds Safety Warnings to Fluoroquinolones

FDA Adds Safety Warnings to Fluoroquinolones

Fluoroquinolones such as Cipro, Levaquin should be reserved for life-threatening infections.

FDA Approves First Absorbable Stent for CAD

FDA Approves First Absorbable Stent for CAD

The Absorb GT1 Bioresorbable Vascular Scaffold System (BVS) is absorbed by the body after about 3 years.

New Drug Cleared to Treat SHPT in Chronic Kidney Disease Patients

New Drug Cleared to Treat SHPT in Chronic Kidney Disease Patients

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Calcifediol formulation is indicated for CKD stage 3 or 4 patients with secondary hyperparathyroidism associated with vitamin D insufficiency.

FDA Strengthens AKI Warning for Some SGLT2 Inhibitors

FDA Strengthens AKI Warning for Some SGLT2 Inhibitors

The Food and Drug Administration (FDA) announced it is strengthening the current warning about the risk of acute kidney injury for drug products containing canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR).

Food Industry Needs to Reduce Sodium, FDA Says

Food Industry Needs to Reduce Sodium, FDA Says

The FDA has developed 2- and 10-year goals to reduce sodium content in both processed and prepared foods.

Nutrition Facts Label Revised

Nutrition Facts Label Revised

Added sugars, relevant portion sizes among the highlights of revision.

Drug Cleared for Refractory Advanced Bladder Cancer

Drug Cleared for Refractory Advanced Bladder Cancer

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Atezolizumab received accelerated FDA approval for patients whose disease has progressed despite platinum-based chemotherapy.

Serious Side Effects With Fluoroquinolones, FDA Warns

Serious Side Effects With Fluoroquinolones, FDA Warns

Agency is recommending that health care providers not prescribe them for certain patients.

FDA's 'Breakthrough' Drug Designation Misunderstood

FDA's 'Breakthrough' Drug Designation Misunderstood

Many believe meds supported by stronger evidence than the law requires to achieve designation.

Metformin Use Expanded to Some Patients With Reduced Kidney Function

Metformin Use Expanded to Some Patients With Reduced Kidney Function

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The diabetes drug was contraindicated due to the risk of lactic acidosis.

2 Diabetes Medications Carry Risks for Kidney Patients, FDA Says

2 Diabetes Medications Carry Risks for Kidney Patients, FDA Says

Drugs containing saxagliptin or alogliptin may be linked to heart failure risk.

FDA Adds Boxed Warning to Opioid Pain Medications

FDA Adds Boxed Warning to Opioid Pain Medications

New labeling rules require immediate-release opioids to carry warnings for the serious risk for misuse.

FDA Tightens Rules for Surgical Mesh in Pelvic Prolapse Repair

FDA Tightens Rules for Surgical Mesh in Pelvic Prolapse Repair

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Agency aims to improve treatment of pelvic organ prolapse.

FDA Allows Blood Donations by Men Who Have Sex With Men

FDA Allows Blood Donations by Men Who Have Sex With Men

National blood surveillance system will help agency ensure safety of the blood supply.

Uptravi Approved for Pulmonary Arterial Hypertension

Uptravi Approved for Pulmonary Arterial Hypertension

Drug found to limit worsening of the disease and reduce the need for hospitalization.

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